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Bristol Falls Further Behind Merck In NSCLC By Pulling Early Combo Filing

 
• By Sten Stovall

Bristol-Myers Squibb's decision not to seek accelerated FDA approval for its Opdivo/Yervoy combo in early lung cancer shocked investors - but analysts still expect a filing to come, albeit later than first thought.

Plan B

Merck & Co. Inc. received some unexpected good news late Jan. 19 when rival Bristol-Myers Squibb Co. said it wouldn't apply for accelerated US approval for its combination of Opdivo (anti-PD-1) plus Yervoy (ipilimumab; anti-CTLA-4) as a first-line treatment for non-small cell lung cancer (NSCLC). The move puts Bristol's IO combo's prospects even further behind Merck's Keytruda (pembrolizumab), which last week was accepted for accelerated review in that indication by the FDA in combination with chemotherapy.

Bristol, in a terse announcement, said it made the decision to hold early fire based on "a review of data available at this time" but gave no more details, "to

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